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Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Trial Profile

Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Dec 2025

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At a glance

  • Drugs Alemtuzumab (Primary) ; Lasmecabtagene timgedleucel (Primary) ; Cyclophosphamide; Fludarabine; Rituximab
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Registrational
  • Acronyms BALLI-01
  • Sponsors Cellectis

Most Recent Events

  • 07 Nov 2025 According to a Cellectis media release, Following successful End-of-Phase 1 meetings with the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Cellectis provided a registration path for lasme-cel in r/r ALL. Cellectis anticipates submitting a Biologics License Application (BLA) in 2028.
  • 07 Nov 2025 According to a Cellectis media release, interim data from the trial will be presented at the ASH 2025
  • 03 Nov 2025 According to a Cellectis media release, company announced the acceptance of abstracts for poster presentationat the American Society of Hematology (ASH) 2025 annual meeting taking place from December 6 to 9, 2025, in Orlando, FL.

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